By Robert Martin, InvestorPlace Writer|May 22, 2017, 11:12 am EDT Puma Biotechnology Inc (NASDAQ:PBYI) jolted as much as 80% higher on Monday morning on news that theU.S. Food & Drug Administration posted a seemingly positive review of Pumas breast cancer drug, neratinib, ahead of an official vote Wednesday. PBYI then settled back to just 60% gains a few hours into the trading day. The FDA asked a few questions and raised a few concerns, notably, tolerability of neratinib in this patient population is a concern given the frequent dose interruptions, reductions, and discontinuations observed, mostly due to diarrhea. Specifically, 95% of patients in clinical trials suffered from diarrhea, with 40% of those suffering the grade 3 form of the side effect. However, on the whole, PBYI investors seemed pleased with what the FDA did (and didnt) ask, taking the review as an encouraging sign ahead of the companys Oncologic Drugs Advisory Committee meeting, scheduled for Wednesday. Neratinib (PB272) is being tested for the extended adjuvant treatment of HER2-positive early stage breast cancer. The drug is meant for patients who have already received Herceptin. The FDA preview said that the primary analysis showed an improvement with neratinib, and that despite changes … Continue reading
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